A Brief Intervention to Improve Medication Knowledge and Adherence Among Family Medicine Patients in South Texas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00846300
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : October 8, 2015
Information provided by:
The University of Texas Health Science Center at San Antonio

Brief Summary:
This study examines a brief physician counseling intervention to improved medication knowledge and compliance in family medicine patients who have diabetes, hypertension or high cholesterol.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Hyperlipidemia Hypertension Behavioral: Physician counseling for health behavior change Not Applicable

Detailed Description:

This study examined a brief intervention to improve medication knowledge and compliance in family medicine patients. The study was conducted in a network of six family medicine residency programs in South Texas, funded by a grant from the Health Research Services Administration. Family medicine patients were invited to participate in the study if they took medicines for type 2 diabetes, hypertension, or hyperlipidemia and responded "yes" to the screening question: "Do you sometimes have trouble taking all your medications as prescribed?"

At enrollment, clinic staff administered a Medication Survey to patients to assess the variables: readiness to change, reported medication knowledge; reported compliance, and predictors of knowledge and compliance. Self-reports of compliance were validated with a social desirability scale, and with physician impressions. Six and twelve weeks post-enrollment, interviewers administered followup surveys by telephone to assess change over time in medication knowledge and compliance. One year post-enrollment, investigators conducted a chart review to examine changes in health outcomes: blood pressure or HbA1c or cholesterol levels, and number of hospitalizations.

Three physicians per clinic site (18 total) conducted medication interventions for the purpose of this study. This intervention was brief behavior change counseling done in the context of a routine office visit, guided by simple strategies outlined in Rollnick et al (1999). First, physicians reviewed subjects= medication regimen and addressed their concerns. We selected a simple strategy from Rollnick et al. - a brainstorming session - that built patients' confidence to change health behaviors. Afterward, physicians offered pillboxes to patients who desired them, and reviewed potential adverse reactions to medicines. One week after the intervention, physicians telephoned patients to reinforce behavior change and to answer questions about the medications. Prior to training physicians to conduct this intervention, we enrolled five subjects per physician into a control group. We attempted to blind physicians to these patients= enrollment status; usual care was provided to control subjects. After training, enrollees' charts were flagged so that physicians knew to conduct the intervention. We sought five patients per physician to receive the intervention.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: An Intervention to Improve Medication Knowledge & Compliance Among Family Practice Patients in South Texas: An RRNEST Study.
Study Start Date : August 2001
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Intervention Details:
    Behavioral: Physician counseling for health behavior change
    Physician counseling for health behavior change, compared to a no-counseling comparison group

Primary Outcome Measures :
  1. Change in self-reported medication knowledge [ Time Frame: 6 and 12 weeks post-intervention ]
  2. Change in self-reported medication compliance [ Time Frame: 6 and 12 weeks post intervention ]
  3. Change in HbA1c for patients with Diabetes [ Time Frame: 1 year post intervention ]
  4. Change in Lipids [ Time Frame: 1 year post intervention ]
  5. Change in blood pressure [ Time Frame: 1 year post intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sometimes has trouble taking medicines as they're prescribed
  • Has diabetes type 2, or hypertension, or high cholesterol for which they take prescription medicines
  • Is a patient of 18 doctors conducting the intervention

Exclusion Criteria:

  • Subjects under age 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00846300

United States, Texas
Christus Memorial Hospital
Corpus Christi, Texas, United States, 78405
Valley Baptist Family Medicine Residency Program
Harlingen, Texas, United States, 78550
Laredo Medical Group
Laredo, Texas, United States
McAllen Family Medicine Residency Program
McAllen, Texas, United States, 78503
Family Medicine Residency Program, Christus Santa Rosa Hospital
San Antonio, Texas, United States, 78207
Dept Family & Community Medicine, UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Principal Investigator: Sandra Burge, Ph.D. University of Texas Health Science Center - San Antonio

Responsible Party: Sandra Burge, Ph.D., UTHSCSA Identifier: NCT00846300     History of Changes
Other Study ID Numbers: HP000016-01
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015

Keywords provided by The University of Texas Health Science Center at San Antonio:
Patient compliance
Health Behavior
Family Physicians
Primary Healthcare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders